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DRUGS: YOU DON'T NEED A PEDIATRIC STAMP

It is too risky to use 'ad hoc' symbols on the packaging of pediatric medicines, to make them more recognizable.

This is the opinion of the Pediatric Committee of the Emea (European Medicines Agency), which has expressed itself against the adoption of special 'stamps' to more easily identify drugs with an 'ad hoc' approved pediatric indication. The European regulation (n. 1901/2006) on medicines for children intended, in fact, to revolutionize the appearance of packaging with 'ad hoc' symbols, which were useful to parents and paediatricians. But after an analysis of the risks and benefits, the EMEA Pediatric Committee - charged by the European Commission with expressing an opinion on the matter - said it was "unable to recommend to the European Commission the use of symbols" on the boxes of pediatric medicines. which were intended to be of help, but instead risk multiplying the danger of errors, even fatal ones. The Committee's opinion, expressed on 20 December, was disclosed by the European Commission at the end of last week. Eighteen members of the group of experts voted against the adoption of the symbols, Apm reports, with only four votes in favour. In short, according to the specialists, any 'stamps' would be more of an advantage from a marketing point of view than a real utility for consumers. The danger is considerable, they warn, especially since some drugs with a pediatric indication - if taken in incorrect dosages or without indication - could have fatal effects for young patients. From Doctornews 07-02-08

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco